Label: DECOLORIZED IODINE- alcohol liquid 

  • Label RSS
  • NDC Code(s): 0295-1183-31
  • Packager: Denison Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/09

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 48.0%

    Close
  • Purpose

    First aid antiseptic

    Close
  • Use      

    first aid to help prevent infection in minor cuts, scrapes, and burns.

    Close
  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Close
  • When using this product 

    do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Close
  • Stop use and consult a doctor 

    if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

    Close
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions  

    • clean the affected area.
    • apply a small amount of this product on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
    • if bandaged, let dry first.
    Close
  • Other Information 

    store at room temperature

    Close
  • Inactive ingredients 

    ammonium hydroxide, iodine, potassium iodide, and purified water

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 0295-1183-31

    Decolorized Iodine

    Iodides Tincture

    FIRST AID ANTISEPTIC

    Contents 1 FL. OZ. (30mL)

    PRINCIPAL DISPLAY PANEL
NDC 0295-1183-31
Decolorized Iodine
Iodides Tincture
FIRST AID ANTISEPTIC
Contents 1 FL. OZ. (30mL)

    Close
  • INGREDIENTS AND APPEARANCE
    DECOLORIZED IODINE 
    iodides tincture liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0295-1183
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 0.48 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    AMMONIA  
    IODINE  
    POTASSIUM IODIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0295-1183-31 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part331 07/01/1964
    Labeler - Denison Pharmaceuticals, Inc. (001207208)
    Close